Intricacies of drug making and the law

Published April 02. 2013 12:01AM

Some of the most important decisions that could influence the future of drug discovery are happening not in laboratories, or even corporate board rooms, but instead in courtrooms both in the United States and globally. At issue is striking a balance between making drug discovery profitable and the moral imperative of providing access to medicines that can cure disease, reduce suffering and extend life.

How these legal and ethical issues play out has implications for the health of every individual. It also has economic repercussions, including right here in southeastern Connecticut where Groton is home to Pfizer's largest research facility, and in a state that aspires to become a leader in the biosciences.

If drug costs are too high, those who need medicines cannot get them. But if pharmaceutical corporations cannot realize a return on their enormous investment in drug discovery, most of it spent researching compounds that lead to dead ends, development will suffer and fewer drugs will be discovered.

Indicative of this debate and its potential impacts was Monday's landmark decision by India's Supreme Court rejecting Novartis AG's attempt in 2006 to patent Gleevec in that country. India's patent office had refused the request by the Swiss pharmaceutical company, finding that the leukemia drug was not a new drug, but a variant on an early medication.

Monday's ruling upheld that decision. It sets a precedent that could prevent pharmaceutical companies from obtaining fresh patents in India on any drug that is not a definitively new compound.

The implications are significant.

By some estimates an expanding middle class in India will boost pharmaceutical sales seven-fold by 2020, up from $11 billion last year. The big beneficiary of the court's decision, and the expected growth in drug sales, should be India's already substantial generic drug industry. With $26 billion in sales, it supplies a substantial amount of the cheap medicine used in the developing world.

Groups focused on global health care, including Doctors Without Borders, say the precedent set by the decision is critical in assuring the world's poor have access to medicine. Gleevec, for example, costs about $2,600 a month compared to $175 for its generic version.

There is a need to set limits on the ability of pharmaceutical companies to extend patent protection, and block generic competition, by tweaking existing medicines, a practice so common it has a name - "evergreening."

Novartis argued that Gleevec was in many respects a new drug, more easily absorbed and effective. A Novartis spokesman warned that, given the decision, the company will carefully evaluate whether to introduce new and improved drugs in India.

There's the rub. Large pharmaceutical companies will continue to dominate drug research and development. They need intellectual property protection. If that protection erodes too much it will inhibit investment in research, particularly for drugs without large-scale disease treatment potential.

Until 1995 India offered no patent protection for drug compounds. That changed with its joining the World Trade Organization. The WTO could take the lead in working towards some international consensus, binding on members, on what constitutes a truly new medicine, deserving of patent protection.

Meanwhile, the U.S. Supreme Court will soon issue its own decision in a case that could influence the cost of medicines and their availability. At issue in Mutual Pharmaceutical Co. v. Bartlett is whether a plaintiff can sue for damages caused by "defective design," even if a drug won approval from the Food and Drug Administration.

Courts have traditionally allowed lawsuits only when a drug company failed to warn patients about potential dangerous side effects or withheld information from the FDA during the approval process. In this case, however, a generic version of the anti-inflammatory drug sulindac did contain warnings about the rare side effect called Stevens-Johnson syndrome that caused Ms. Bartlett burns over much of her body.

Ms. Bartlett argued the FDA should not have approved the drug and it should not have have been sold. The New Hampshire courts let the case go forward, and a jury awarded $20 million.

The Supreme Court should overturn this verdict. If drug makers can be held liable for adverse side effects listed in FDA-approved warnings, it would have a chilling effect on drug development and increase already high drug costs.